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CompletedNCT01926080Updated Jan 7, 2025

Impact of a Neonatal-Bereavement-Support DVD on Grief

An interventional study of DVD Intervention Arm in Grief and Depressive Symptoms, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Experts agree that neonatal death has long-term impact on parents. Many parents experience sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child. There are no prospective studies that evaluate the effectiveness of bereavement management and follow-up on the grief process following the death of a newborn. The purpose of this study is to evaluate the impact of a neonatal intensive care unit (NICU) bereavement support program and the use of a newly designed family-centered bereavement DVD. This educational DVD includes personal interviews with parents, grandparents and siblings who have experienced the lost of a baby in the NICU.

Read the detailed description

The care given to a family before and following a neonatal loss can set the stage for a family's entire grieving process. For many parents, the support they receive from health care providers after the loss of a baby may have crucial effects on the family's ability to appropriately respond. It is essential for nurses, practitioners, physicians, and chaplains to provide compassionate care that meets or exceeds parents' expectations. However, supporting families following the death of an infant is particularly challenging. There is limited bereavement intervention guidance in the literature that may benefit grieving parents. Follow-up care is a crucial part of bereavement management of families whose babies have died. The bereavement committee at St. Louis Children's Hospital (SLCH) is a multi-disciplinary team, which includes representation from neonatal nurses and nurse practitioners, neonatologists, social workers, chaplains, patient-care associates, and former bereaved parents. Their role is to assist families both at the time of an infant's death and in securing their baby's personal belongings after the family leaves the hospital. In addition to receiving bereavement materials, which is considered standard-practice of care in the NICU at SLCH following the death of an infant, half of the parents enrolled in the study will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'.

02

Conditions studied

  • Grief
  • Depressive Symptoms

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Keywords

  • Depression
  • Spirituality
  • Neonatal death
  • Bereavement
  • Randomized controlled trial
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 107 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • At least 18 years of age
  • Any parent who has experienced the death of a baby in the NICU at SLCH or has had a baby treated in the NICU who has died at home with hospice care

Exclusion criteria

Exclusion Criteria:

  • Babies who are at home longer than one month with hospice care will be excluded
  • Those who are not English speaking or who are illiterate
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
107 participants (actual)

Study arms

  • Other
    DVD Intervention Arm

    Half of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'. A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group.

    Other: DVD Intervention Arm

  • No intervention
    Standard Bereavement Care

    Those randomized to control group (no DVD) Standard Bereavement Care Arm receive the bereavement materials given to families as standard-practice of care in the NICU at SLCH following the death of an infant

Interventions

  • OtherDVD Intervention Arm

    Half of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'. A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group.

06

What researchers measure

Primary outcomes

  1. Parental Grief

    To characterize and describe changes in grief at 3 months and 12 months in a cohort of parents who have experienced death of a newborn infant in the NICU.

    Time frame: 3 and 12 months following death of a newborn

Secondary outcomes

  1. Depressive Mood Symptoms

    To characterize and describe changes in depressive mood symptoms at 3 months and 12 months in a cohort of parents who have experienced death of a newborn infant in the NICU.

    Time frame: 3 and 12 months following death of a newborn

07

Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
08

References and documents

Publications

  • Rosenbaum JL, Smith JR, Yan Y, Abram N, Jeffe DB. Impact of a Neonatal-Bereavement-Support DVD on Parental Grief: A Randomized Controlled Trial. Death Stud. 2015 Jan-Jun;39(1-5):191-200. doi: 10.1080/07481187.2014.946628. Epub 2014 Dec 20. PubMed 25530502 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01926080
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
Aug 20, 2013
Start date
Jan 2008
Primary completion
Feb 2011
Completion
Aug 9, 2017
Last update
Jan 7, 2025

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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